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ACTIVE NOT RECRUITING
NCT04003805
PHASE1

Biomarkers of Exposure and Effect in Standardized Research E-cigarette (SREC) Users

Sponsor: Masonic Cancer Center, University of Minnesota

View on ClinicalTrials.gov

Summary

This study is focused on characterizing the toxic and carcinogenic potential of the Standardized Research E-cigarette (SREC) developed by the National Institute on Drug Abuse. In the environment of continuously changing e-cigarette market, SREC was developed as a model e-cigarette that will remain available for an extended period of time and can be used as a bridging element in various studies aimed at evaluating the value and limitations of e-cigarettes as tobacco risk reduction tools. Our overall goal is to generate initial reference data on chemical exposures and associated effects in smokers switching to SREC.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

47

Start Date

2022-05-11

Completion Date

2026-05-20

Last Updated

2026-01-29

Healthy Volunteers

Yes

Interventions

DRUG

Standardized Research E-cigarette (SREC)

The device operates at a single output voltage (3.30 ± 0.05 V) and uses sealed disposable 3-mL cartridges with tobacco-flavored e-liquid (\~350 puffs/cartridge). The concentration of nicotine in e-liquid is 15 mg/mL, and the vehicle composition is 50:50 propylene glycol and glycerin. The device uses a battery that can be recharged via a micro USB port. A single charge is designed to sustain more than 400 puffs, which is more than the capacity of an e-liquid cartridge. The e-liquid and the aerosol are well-characterized in terms of chemical impurities and by-products (such as aldehydes), which are minimal. Additional information, including the results of pharmacokinetics study is available via NIDA website: https://www.drugabuse.gov/funding/supplemental-information-nida-e-cig

Locations (1)

University of Minnesota, Masonic Cancer Center

Minneapolis, Minnesota, United States